Application 078805
- Type
- ANDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 40MG/2ML (20MG/ML) | No | No |
| 002 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | INJECTABLE;INJECTION | 100MG/5ML (20MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078805-001 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | ||
| A078805-002 | IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078805-001 | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078805-002 | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE / INJECTION | 2008-04-21 | 782e0a99824c… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Camptosar | IRINOTECAN HYDROCHLORIDE | Pharmacia & Upjohn Company LLC | e518dfc6-7e93-4fee-a66c-51e1ab71c056 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | d04f2471-3085-4fc8-a657-bb3918d48e6e | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan hydrochloide | IRINOTECAN HYDROCHLOIDE | Xiromed LLC | b26e5d27-dba5-7538-9e7b-48b358998cbb | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Sagent Pharmaceuticals | caab50e6-0dad-4ddd-9a6c-96cc2b87aee7 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Hospira, Inc. | 5c527c2e-9062-4afe-dbbb-f650db3a340f | 2025-11-03 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | Eugia US LLC | 7a30d551-9ea7-47ea-9073-f541bff457a3 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE |
| Irinotecan hydrochloride | IRINOTECAN HYDROCHLORIDE | Actavis Pharma, Inc. | 5e1fdcaa-918f-4cd8-9c7a-4c538d866198 | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE |
| Onivyde | IRINOTECAN HYDROCHLORIDE | Ipsen Biopharmaceuticals, Inc. | c8b58efa-1820-48a4-b70d-62918fc4abfc | 2025-03-03 | Boxed warning, Warnings, Adverse reactions | IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Apotex Corp. | 8fe98987-e526-4729-a8f4-c7230f424108 | 2024-07-04 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Apotex Corp. | 85ed6019-f462-4abe-a89e-ad991623c86d | 2024-06-28 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Fresenius Kabi USA, LLC | ee45f127-8450-4455-a945-a1f5707f1d39 | 2023-01-19 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan hydrochloride | IRINOTECAN HYDROCHLORIDE | Northstar Rx LLC | 4f98e9ed-f7b1-5346-af72-fccb0abf3f4b | 2022-03-31 | Boxed warning, Warnings, Adverse reactions | Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan hydrochloide | IRINOTECAN HYDROCHLOIDE | Gland Pharma Limited | de634e80-328a-4473-b395-0172683a2411 | 2022-03-03 | Boxed warning, Warnings, Adverse reactions | Irinotecan hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Qilu Pharmaceutical Co., Ltd. | afcdde49-ec0c-4c56-a1af-2917185b1a08 | 2021-03-10 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 9c6aa884-750e-4b11-9955-bc7ab6e9c2ad | 2020-06-28 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |
| Irinotecan Hydrochloride | IRINOTECAN HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | be716692-6b4f-47b6-83d1-01665861626b | 2020-06-23 | Boxed warning, Warnings, Adverse reactions | Irinotecan Hydrochloride IRINOTECAN HYDROCHLORIDE |